Article Text
Abstract
Background and importance In our country, considerable progress has been made in recent years since the establishment of the clinical therapeutic position reports (TPR) in 2013, but more research is needed about their impact on decision making.
Aim and objectives To determine the value of immunotherapy for cancer therapeutic positioning reports (ITc-TPR) in clinical practice.
Material and methods A nationwide survey was designed for hospital pharmacists and clinical oncologists of the ITc-TPR, published between May 2013 and March 2020. The main variables collected were: sociodemographics of the hospitals and health professionals, approval criteria and variables related to the acceptance of the ITc-TPR recommendations.
Results During the study period, 46 ITc-TPR of 22 active substances were published. 27 health professionals answered the survey, 81.5% hospital pharmacists and 18.5% oncologists, ascribed to 24 hospitals in the national territory. 33.3% of the professionals had participated in the development of some TPR-ITc. In 45.8% of hospitals, incorporation of ITc was decided at the regional level, and in 66.7% of hospitals the drug and therapeutic indication with ITc-TPR published should be re-evaluated by the pharmacy and therapeutics hospital commission. In 50%, the authorised indications were the same as those of the ITc-TPR and 70.8% followed the recommendations of the ITc-TPR.
48.1% of the professionals who responded to the survey believed that ITc-TPR have eliminated barriers for access of patients to ITc, have decreased the variability of clinical care and promoted equity in the national territory. 66.7% believed the incorporation of the drug into clinical practice was faster if there was a published ITc-TPR. The main limitations for patients to access ITc were: not financed by the national health system (55.6%), high cost (37.1%) and the restrictions at the autonomic level (29.6%). The aspects of the ITc-TPR that should be improved were: pharmacoeconomic evaluation (66.7%), conclusions useful for clinical practice (70.4%), a single evaluation at the national level (70.4%) and decisions binding (80.5%).
Conclusion and relevance ITc-TPR is a useful and well established tool at the national level for the positioning of a new drug. The results of the survey will allow the development of strategies to improve ITc-TPR.
References and/or acknowledgements Acknowledgements: AEMPS, GEDEFO, participants, directors, teachers and tutors of Máster Inmunoterapia del Cáncer.
Conflict of interest No conflict of interest